Mastering the FDA Pathway: 2025 Guide for IVF Innovators

This post launches our new Regulatory Affairs series, giving IVF innovators region-by-region roadmaps to regulatory clearance.

1. Why the U.S. still matters

• Largest single IVF-device market (~US $1.3 B).
• First adopters of AI-enabled lab tech.
• FDA clearance is the gold stamp for global distributors.

 

2. Quality Management System Regulation (QMSR) — NEW

In February 2024 FDA finalized the Quality Management System Regulation (QMSR), replacing the old 21 CFR 820 QS Regulation. QMSR incorporates ISO 13485:2016 by reference and mandates risk-based quality management across the entire product life-cycle, not only at initial audit fda.govfederalregister.gov.

What it means for you

• Align your QMS with ISO 13485 before design-freeze.
• Maintain documented risk files that link hazards to design controls.
• Expect FDA inspectors to sample post-market surveillance activities during routine audits.

 

3. Classify your IVF device

Typical IVF Product	FDA Class	Product Code	Pathway
Embryo-transfer catheter	II	MQF	510(k)
Culture media / oil	II (special controls)	MQL	510(k)
Time-lapse incubator	II	MNB	De Novo → 510(k)
AI embryo-scoring software	II (SaMD)	QDQ	De Novo / 510(k)
Laser-assisted hatching	III	LAS	PMA
Combination products (e.g., media + growth factor)	Device/biologic	—	PMA or BLA / CBER-CDRH joint review

Tip – No predicate? File a De Novo to create one; subsequent models may follow the 510(k) route.

 

4. Submission routes & 2025 fees*

Route	Use-case	Avg. FDA days**	FY 2025 Fee	FY 2024 Fee (ref)
510(k)	Predicate exists	124	$25,347	$21,760
De Novo	First-of-kind, moderate risk	6–9 mo	$132,874	$114,836
PMA	High-risk / combo	12–18 mo	$483,560	$417,973
Establishment registration	Annual	—	$9,280	$7,653

*Fees published each August; confirm current rates before submitting fda.govfederalregister.gov.
**MDUFA V decision goals.

 

5. Regulatory checklist (concept → clearance)

1. Determine regulation & product code
2. Appoint U.S. Agent & register establishment (FDORA eSTAR portal).
3. Implement QMSR (ISO 13485-aligned).
4. Generate technical file
   • Bench, biocompatibility, sterility.
   • AI/ML: algorithm description, training data diversity, bias analysis, and post-market model-maintenance plan fda.govfda.gov.
5. UDI & GUDID
   • Submit Device Identifier within 60 days of clearance; multi-component ART kits must list the highest-risk component fda.govfda.gov.
6. Labeling / IFU – reflect cleared indications only.
7. Submit with eSTAR (now compulsory for 510(k), De Novo from Oct 2025) fda.gov.
8. Interactive review – respond rapidly to RTA/AI letters.
9. Post-market
   • MDR, CAPA, and—new for AI/ML devices—continuous performance monitoring & real-world accuracy reports via FDA’s Digital Health Center of Excellence.

 

6. Common IVF pitfalls & fixes

Pitfall	Impact	Fix
Predicate outside ART scope	NSE decision	Match intended use (embryo vs IUI).
Incomplete embryo-toxicity data	AI hold	Include mouse-embryo assay + endotoxin testing.
Missing SaMD documentation	RTA refusal	Provide software traceability & cybersecurity plan (FDA Cybersecurity Guidance) fda.gov.
Forgetting GUDID upload	Compliance warning	Upload DI within 60 days; link production IDs for kits.

7. Accelerators (and their new limits)

Tool	Still works?	2025 Notes
Q-Sub (Pre-Submission)	✔	FDA now issues written feedback first; meetings reserved for complex issues.
Third-Party 510(k) Review	⚠️	Not eligible for AI/ML software or most combination products (see product codes QKQ, QIH) accessdata.fda.govaccessdata.fda.gov.
Special Controls	✔	ART media & catheters covered—leverage to avoid clinical trials.
Parallel FDA/CMS Review	✔	Worth it for AI diagnostics needing reimbursement.

8. Commercialisation after clearance

1. Cybersecurity & HIPAA – connected devices must ship with SBOMs and meet PATCH-within-30-days expectation.
2. Marketing claims – new FTC rule bars “clinically proven” language without FDA-reviewed evidence.
3. State regulations – California (SB 546) and Texas (HB 3168) now require adverse-event reporting at clinic level; distributors must support customers accordingly.
4. Distribution – choose reps who:
   • Know 510(k)/UDI nuances.
   • Provide field service logs aligned to QMSR.
   • Have reach in the 20 largest U.S. IVF clinics.

 

9. Key takeaways

1. QMSR is live—ISO 13485 compliance is now mandatory.
2. Most IVF devices stay in Class II → 510(k), but AI tools may need De Novo.
3. UDI/GUDID submission within 60 days is non-negotiable.
4. AI/ML devices carry extra post-market monitoring obligations.
5. Third-Party review no longer speeds AI/ML devices—plan timelines accordingly.
6. After clearance, success hinges on reg-literate distributors—find them on FinDBest IVF.

 

 

Ready to tackle the FDA and secure top-tier U.S. partners?

Send us an email at info@findbestivf.com to get  a promo code to find distributors for the USA market.

Next in the series → “China’s NMPA Pathway for IVF Devices.”